B. Braun Stimuplex HNS 12, Руководство пользователя

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Conformity with the following standards:
DIN EN 50581 Technical documentation for the assessment of electrical and electronic products with respect to the
restriction of hazardous substances
DIN EN 1041 Information supplied by the manufacturer with medical devices
93/42/EEC and MPG Council Directive 93/42/EEC of 14 June 1993 concerning medical devices - Annex I
(Essential Requirements); Annex II (without section (4))
Directive 2006/66/
EC and ElectroG
(German Battery
Law) Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries
and accumulators and waste batteries and accumulators
Directive 2011/65/
EU Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction
of the use of certain hazardous substances in electrical and electronic equipment (RoHS II)
Directive 2012/19/
EU Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical
and electronic equipment (WEEE)
FDA 21 CFR 21
Part 801 FDA - Code of Federal Regulations Title 21 Part 801 - Subpart A - Labeling
FDA 21 CFR 21
Part 820 FDA - Code of Federal Regulations Title 21 Part 820 - QS regulation - Subpart K - Labeling and
Packaging Control
FDA 21 CFR 21
Part 830 FDA - Code of Federal Regulations Title 21 Part 830 - Unique device identification
IEC 60601-1 Medical electrical equipment –Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for safety – Collateral standard:
Electromagnetic compatibility - Requirements and tests (applicable to Ed. 3 and 4)
IEC 60601-1-4 Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard:
Programmable Electrical Medical Systems